Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

Overview

The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.

Full Title of Study: “A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients”

Study Type

• Study Type: Interventional
• Study Primary Completion Date: March 2012

Interventions

• Drug: Tramadol hydrochloride/Acetaminophen Tab.
• Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

Arms, Groups and Cohorts

• Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.
• Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.

Clinical Trial Outcome Measures

Primary Measures

• Changes in ‘100 mm pain VAS’ value from baseline
  • Time Frame: 0, 1, 7, 14, 28 day

Participating in This Clinical Trial

Inclusion Criteria

1. Adult males/Females aged over 20 years 2. Patient with low back pain who needs analgesic administration 3. Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification 4. Pain VAS Value over 40 mm 5. Subjects who voluntarily or legal guardian agreed with written consent Exclusion Criteria:

1. Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension 2. Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease) 3. Patients who had taken back surgery within 24 weeks from the screening point 4. Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point 5. Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Daewon Pharmaceutical Co., Ltd.
• Provider of Information About this Clinical Study
  • Sponsor